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LabAspire Program Manual
Disclaimer: The LabAspire Program Manual (the “Manual”) is published by LabAspire, a nonprofit educational program in partnership with the California Association of Public Health Laboratory Directors (CAPHLD) and the California Department of Public Health (CDPH) Center for Laboratory Sciences (CLS) and is provided solely for general informational purposes. The Manual is intended to serve as a general reference for current and prospective participants in the LabAspire Program, which focuses on leadership development and training related to public health laboratory science and administration. Nothing contained in the Manual shall be construed as professional medical, clinical, legal, regulatory, academic, or career advice, nor as a substitute for independent professional judgment. The Manual does not establish standards of care, clinical protocols, regulatory requirements, or operational mandates. LabAspire makes no representations or warranties of any kind, whether express, implied, statutory, or otherwise, including but not limited to warranties of accuracy, completeness, reliability, suitability, or availability, with respect to the Manual or any information contained therein.
Table of Contents
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Introduction to the Program
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Background of the Program
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LabAspire Committee Roles, Responsibilities, and Duties
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Description of the Program
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General Objectives
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Orientation to Host Laboratory Policies and Procedures
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Public Health Laboratory Missions
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Regulatory Compliance
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Facilities Management
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Management Principles
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Management Operations
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Information Technology
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Environmental Laboratory Accreditation Program (ELAP)/TNI 2016
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Other Programs
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Membership and Committee Participation
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Program Activities
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Meetings
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Curriculum, resources, online trainings
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Additional Rotations (varies)
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Board Exam Information
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Applications and Attestation
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Application for California Public Health Lab Director through CDPH-LFS
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Performance Metrics
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Fellowship Expectations
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Host Laboratory Expectations
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Program Evaluations for Host Laboratory and LabAspire Fellows
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Evaluation Criteria
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Termination Process
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Change Requests
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Appendices
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Syllabus
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Activity List
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Quarterly Progress Reports
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Program calendar (to be updated with ABB exams and DrPH instructional schedule); real-time calendar will be maintained on Google Drive
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Program Contacts
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LabAspire Committee Roles, Responsibilities and Duties
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Application Form for Host Laboratories
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Application Form for Fellows
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Change request form
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Funding
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Requirements for Laboratory Director
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FAQs
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References and Contributors
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LABASPIRE LABORATORY DIRECTOR FELLOWSHIP
TRAINING PROGRAM
INTRODUCTION TO THE PROGRAM
The LabAspire Laboratory Director Fellowship Program, overseen by the California Department of Public Health (CDPH) Center for Laboratory Sciences (CLS) and the California Association of Public Health Laboratory Directors (CAPHLD), is aimed at developing core leadership and administrative skills for selected candidates to qualify to become California Public Health Laboratory Directors.
Public Health Laboratory Directors (PHLDs) must meet federal CLIA regulations to direct a laboratory, including possession of an acceptable doctoral degree, two years of laboratory training or experience, or both; and two years of laboratory experience directing or supervising high complexity testing (42 CFR §493.1443; see Appendix 10). Additionally, the California Code of Regulations specifies that the Director of a California Public Health Laboratory must be a certified Public Health Microbiologist (PHM) with four or more years of experience in public health laboratory work (17 CCR §1302)1.
BACKGROUND OF THE PROGRAM
From the 1970s until the mid-1980s, the California Department of Health Services offered a postdoctoral residency program in medical microbiology and public health. This program was approved by the American Academy of Microbiology Continuing Postgraduate Educational Program (CPEP) and led to each graduate being eligible for certification as a Diplomate by the American Board of Medical Microbiology (ABMM). Unfortunately, this program was discontinued due to a lack of funding in the mid-1980s. An impending shortage of qualified personnel to fill local public health laboratory director positions in California prompted the legislature to approve funding for the LabAspire Program in 2005, supporting the public health laboratory infrastructure. The LabAspire program included a Postdoctoral Residency Training Program in Clinical and Public Health Microbiology and supported bachelor’s and graduate-level students in public health through various educational and training requirements. Funding for the LabAspire Program was discontinued in 2012. However, the need for qualified candidates to direct California’s Public Health Laboratories (PHLs) continued to increase. The California Department of Public Health (CDPH) Public Health Laboratory System Working Group (PHLSWG), a stakeholder group formed to discuss strategies to strengthen the PHL system in California, published a white paper specifically recommending funding an Assistant Laboratory Director training program at local PHLs as the fastest method to develop California PHLDs2. This method was recommended because it would provide much-needed workforce capacity, allow for mentoring opportunities between PHLDs and trainees, and facilitate a smoother transition when the current PHLDs retired.
From 2017 to 2019, the California Department of Public Health was able to provide short-term funding through the Centers for Disease Control and Prevention (CDC) Public Health Emergency Preparedness Program (PHEP) to support limited reinstatement of the LabAspire Program. Additional short-term funding to continue the limited reinstatement of LabAspire from 2021 to 2024 was identified in the COVID ELC Enhancing Detection Strengthening Public Health Preparedness Supplement 1. Short-term funding for LabAspire Public Health Laboratory Director training was also specifically allocated in State Budget Acts AB 179 Item 4265-001-0001 Provision 31 and Item 4265-111-0001 Provision 18 (2022-2025), AB 102 Item 4265-001-0001 Provision 13 and Item 4265-111-0001 Provision 6 (2023-2026), and AB107 Item 4265-001-0001 Provision 11 and Item 4265-111-0001 Provision 6 (2024-2027) as part of the Public Health Equity and Readiness Opportunity (HERO) Initiative. In all these programs, financial support is provided to local public health laboratories to support the training of Assistant Laboratory Directors for succession planning. Post-graduate Fellows are placed in local public health laboratories to receive managerial experience, and financial support for graduate-level education is available to experienced laboratory supervisors and managers to complete educational requirements. In this way, individuals who are already partially qualified can complete the requirements to become a laboratory director under the Clinical Laboratory Improvement Amendments (CLIA) 42 CFR §493.1443 and California Code of Regulations 17 CCR §1302.
LABASPIRE COMMITTEE ROLES, RESPONSIBILITY, AND DUTIES
The LabAspire Committee comprises members from CAPHLD and CDPH who are responsible for LabAspire’s program development and management. Responsibilities include developing training criteria and materials, overseeing host laboratory and Fellow selection, and acting as a liaison to the California Emergency Preparedness Office to facilitate program funding. A more detailed summary of the LabAspire Committee’s Roles, Responsibilities, and duties, along with its current members, is outlined in Appendix 6.
DESCRIPTION OF THE PROGRAM
The LabAspire Laboratory Director Fellowship provides doctoral education opportunities for experienced laboratory supervisors and managers, as well as experience in administrative and technical skills needed to lead a public health laboratory for doctoral-level scientists. Both prospective and admitted Fellows may participate in LabAspire training activities before their official Fellowship start date. Each Fellow is assigned to a sponsoring Public Health Laboratory or group of laboratories for the duration of their Fellowship. To meet LabAspire requirements, Fellows must be in a full-time supervisory position in a local California Public Health Laboratory; they may work as Assistant Laboratory Directors, Laboratory Managers, or Supervisors. Fellows work in sponsoring Public Health Laboratories to gain an understanding of the Public Health Laboratory system and how it relates to communicable disease, prevention, surveillance, and control. LabAspire training includes but is not limited to regulatory requirements, laboratory budgeting and finance, laboratory administration, safety, quality assurance, technical problem solving, personnel management, and networking with public health partners. LabAspire training may also include rotations at other health departments, clinical or public health laboratories, and related programs. Sponsoring Public Health Laboratories are responsible for supervising their Fellows’ training and progress in completing program requirements. Fellows must demonstrate satisfactory progress every year to continue participating in the LabAspire program. Fellows will be required to take board examinations and meet program benchmarks to continue in the program. It is important to note that completion of the Fellowship program does not guarantee a new job and/or promotional opportunity. In the event there are changes in funding, Fellows may still participate in LabAspire training activities.
LAB ASPIRE PROGRAM ELIGIBILITY REQUIREMENTS
The LabAspire Fellowship program is open to U.S. citizens and permanent residents.
Applicants may be internal applicants currently certified as Public Health Microbiologists and employed as California Public Health Laboratory line staff with 2 or more years of high-complexity laboratory testing experience, including experience as a PHL Assistant Director, Manager, or Supervisor.
External applicants may possess either a Doctoral degree (PhD, DrPH, ScD, DCLS, MD*, or DO*) in a scientific discipline such as biology, microbiology, chemistry or medicine; or a combination of a Masters’ or Bachelors’ degree in a scientific discipline such as biology, microbiology or chemistry and 2 or more years of high-complexity laboratory testing experience in a California Public Health Laboratory**, including experience as a PHL Assistant Director, Manager or Supervisor. Applicants without a California Public Health Microbiologist license must work with their host Laboratory Director/Manager/Supervisor to complete PHM training within the first year of entering the LabAspire program, and their continued participation in LabAspire is contingent on successful PHM training and certification. These candidates are classified as LabAspire Participants.
Applicants with a master’s or bachelor’s degree and laboratory experience are accepted based on their enrollment in an accredited United States university graduate program to meet the education and training requirements for approved certification boards for Laboratory Directors of High Complexity Testing.
Applicants seeking a master’s degree must declare that they intend to obtain a doctoral degree to become a Public Health Laboratory Director. The LabAspire Program is not intended for individuals desiring an MPH without the possibility of fulfilling this goal.
Applicants must be sponsored by a California Public Health Laboratory; training and experience requirements must be completed in a high complexity CLIA-certified PHL 3.
Notes:
*must be licensed to practice in the State of California; board certification and experience requirements are different from non-medical doctoral degrees 42 CFR 493.1443
**1 year of post-doctoral training in a CLIA-certified clinical laboratory may be substituted for 1 year of required training in a PHL. One year of post-doctoral Fellowship can be substituted for 6 months of PHM training 3.
**42 CFR 493.1443 Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (2)(i) Be a doctor of medicine, a doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and(ii) Have at least 2 years of experience directing or supervising high complexity testing; and(iii) Have at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in § 493.1445 1
LABASPIRE FELLOWSHIP APPLICATION
The LabAspire Fellowship application includes a narrative statement, a letter of recommendation from a CA PHL Director, references from professors, supervisors, or subordinate laboratory staff, curriculum vitae, copies of licenses and certifications, copies of transcripts from all degree-granting institutions, and proof of US citizenship or permanent residency. It is the responsibility of the applicant to ensure all materials are received by CDPH and CAPHLD.
SPONSORING LABORATORY APPLICATION
The sponsoring laboratory application includes a statement of intent, documentation of laboratory certification, a training plan, a training budget, and a letter of support from the local health jurisdiction.
APPLICATION FORMS
LabAspire Fellowship and Host Laboratory application forms and instructions are available on the CAPHLD website https://www.caphld.org/labaspire. Refer to Appendices 7 & 8. Applicants should submit electronic applications and materials to CAPHLD.LabAspire@gmail.com, Shantelle.Lucas@cdph.ca.gov, Wil.Velasco@cdph.ca.gov, and Katya.Ledin@cdph.ca.gov. If funding is available, CDPH will continue to accept applications on an ongoing basis through December 31, 2026.
Only complete applications will be reviewed. Applications will initially be reviewed by the LabAspire Program Manager, and then by a panel representing CDPH and CAPHLD Committee members. After the review, the Program Manager may contact Fellowship candidates and sponsoring laboratories for additional materials and interviews as needed. The same forms are used for both new applications and renewal applications.
Fellows will be required to provide quarterly progress reports, which may include academic transcripts; take board certification exams for Laboratory Directors of High Complexity Testing, such as those offered by the American Board of Bioanalysis (ABB) or American Board of Medical Microbiology (ABMM); and meet program benchmarks to continue in the program. CDPH-LFS will assist with regulatory compliance by reviewing Fellows’ qualifications for board eligibility as needed.
For questions, please contact the LabAspire Program Manager, Dr. Shantelle Lucas, at Shantelle.Lucas@cdph.ca.gov or CAPHLD.LabAspire@gmail.com; LabAspire Program Coordinator, Dr. Hamida Nusrat, at hamida.nusrat@cdph.ca.gov or CAPHLD.LabAspire@gmail.com; and Dr. Katya Ledin at Katya.Ledin@cdph.ca.gov.
PROGRAM REQUIREMENTS
LabAspire Program completion requirements are based on CLIA and California Laboratory Field Services (LFS) regulations for high-complexity clinical Laboratory Director / California Public Health Laboratory Director.
Educational requirements for Fellows needing a doctoral degree
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Doctoral degrees acceptable to CLIA (see 42 CFR §493.1443 for details)
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PhD, DrPH, MD*, DO*, DSc, DCLS
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*must be licensed to practice in the State of California; certification and experience requirements are different from other doctoral degrees
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DrPH: Applicants with a master’s or bachelor’s degree are accepted based on their enrollment in an accredited United States university graduate program to meet the education and training requirements for approved certification boards for Laboratory Directors of High Complexity Testing. Currently, the only online DrPH program directly meeting federal requirements for diagnostic laboratory testing is the University of South Florida DrPH in Public Health and Clinical Laboratory Science and Practice. USF requires five (5) years of laboratory experience to matriculate into the program. The laboratory experience can be in a public health, clinical, or veterinary laboratory. Please visit USF’s website for more information. (https://health.usf.edu/publichealth/apply/doctoral/drph-phclsp) 4LabAspire applicants are responsible for consulting with their Host Laboratory, the LabAspire Committee, and LFS to ensure that their PhD coursework and projects apply to federal and state Laboratory Director requirements and are compatible with PHL employment and supervisory experience requirements.
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PhD: A variety of in-person PhD programs are available from accredited universities. LabAspire applicants are responsible for consulting with their Host Laboratory, the LabAspire Committee, and LFS to ensure that their PhD coursework and projects apply to federal and state Laboratory Director requirements and are compatible with PHL employment and supervisory experience requirements. For PhD programs, careful consideration of in-person course attendance requirements and the development of a well-defined dissertation project with a realistic timeline are essential.
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MPH (prerequisite for DrPH): A variety of online and in-person MPH programs are available from accredited universities. LabAspire applicants are responsible for consulting with their Host Laboratory, the LabAspire Committee, and LFS to ensure that their MPH coursework and projects apply to federal and state Laboratory Director requirements and are compatible with PHL employment and supervisory experience requirements.
Applications to enroll in graduate programs that are not specifically designed to meet national board certification requirements for a high-complexity Clinical Laboratory Director; therefore, will need to be vetted by the LabAspire Program Manager and Committee before enrollment, and will be approved on a case-by-case basis.
California Laboratory Field Services (LFS)Requirements 5-7
PHM experience- See Appendix 6 for Letter of Experience to shorten PHM training.
Public Health Microbiologist (PHM) is the California-specific license required to practice diagnostic microbiology and immunology in all California Public Health Laboratories (CCR Title 17 Section 1079). The California PHM Certification was created in 1939 to specify minimum laboratory personnel standards; it significantly predates the requirements of CLIA 1988. To qualify for certification as a Public Health Microbiologist in California, an applicant must have completed a bachelor’s or higher degree in medical or public health microbiology or an equivalent, scientific major from an accredited university, with coursework approved by LFS. The applicant must also register for the LFS Public Health Microbiologist Trainee License and apply to and complete a state-approved PHM training program at CDPH or an LFS-approved local public health laboratory (CCR Title 17 Section 1079-1080). For applicants with previous diagnostic public health or clinical laboratory training or experience in the United States, including CPEP post-doctoral training programs, there is an experience evaluation form that can be requested from LFS to determine if some or all of the applicant’s previous experience applies to the PHM training requirements. Only United States-based clinical laboratory training and experience is applicable; foreign or non-clinical (e.g., research) laboratory experience will not fulfill the requirements. After completing the PHM training requirements, the trainee must successfully pass the American Association of Bioanalysts (AAB) Board of Registry (ABOR) PHM Certification examination, which is offered twice a year. Note that for most PHLD applicants, the CCR Title 17 Section 1302 PHLD requirements for 4 years of PHM experience begin only after PHM Certification is achieved; therefore, LabAspire Fellows who are not already PHM certified are required to complete their PHM training and exam in the first year of their Fellowship, so that they can quickly get on track to meet the California personnel requirements for PHLD.
Board Certification Requirements
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For PhD, DrPH, DSc, and DCLS degree holders, LFS currently accepts American Board of Bioanalysis (ABB) and American Board of Medical Microbiology (ABMM) Laboratory Director Board Certifications.
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LabAspire Fellows and Host Laboratories are encouraged to familiarize themselves with each certifying organization’s requirements for admission to their board exam. This specific, detailed information is available on the ABB and ABMM websites.
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Fellows pursuing ABB certification may take the Technical Supervisor (TS) exam separately from the General Supervisor (GS) exam. Individuals may be eligible for admission to the ABB TS exam as soon as they complete 1 year of experience as certified or licensed high-complexity diagnostic laboratory testing personnel.
One year of post-doctoral training in a CLIA-certified clinical laboratory may be substituted for 1 year of required training in a PHL. Experience from a clinical laboratory may be substituted for experience in a public health laboratory. NOTE: According to LFS, the Fellow must document prior experience in a CLIA laboratory.
Time Limits for Enrollment in Program
Years of participation in the LabAspire program will be assessed on a case-by-case basis. Depending on the academic and experience requirements, Fellows may be enrolled for up to 5 years to complete doctoral degree requirements and up to an additional 2 years to complete MPH requirements.
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For More Details on Funding and Training
